The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove - Aqua Blue (ablu) / Violet Blue (vblu) / Dark Blue (dkbu).
Device ID | K140610 |
510k Number | K140610 |
Device Name: | NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) |
Classification | Polymer Patient Examination Glove |
Applicant | HARTALEGA NGC SDN. BHD. C-G-9, JALAN DATARAN SD1 Bandar Sri Damansara, MY 52200 |
Contact | Nurul Aisyah Kong |
Correspondent | Nurul Aisyah Kong HARTALEGA NGC SDN. BHD. C-G-9, JALAN DATARAN SD1 Bandar Sri Damansara, MY 52200 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-10 |
Decision Date | 2014-06-20 |
Summary: | summary |